ID

12931

Descrizione

Long-Term Therapy With Ribavirin for Chronic Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT00001854

collegamento

https://clinicaltrials.gov/show/NCT00001854

Keywords

versioni (1)
  1. 06/01/16 06/01/16 -
Titolare del copyright

CC BY-NC 3.0

Caricato su

6 gennaio 2016

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0
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Eligibility Chronic Hepatitis C NCT00001854

Inglese

Eligibility Chronic Hepatitis C NCT00001854

1 moduli  
Criteria
Descrizione

Criteria

age above 18 years, male or female.
Descrizione

age above 18 years, male or female.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
elevated alanine (alt) or asparate (ast) aminotransferase activities averaging at least twice the upper limit of normal on three determinations taken at least one month apart during the previous 6 months. the mean of these three determinations will be defined as "baseline" alt and ast levels.
Descrizione

elevated alanine (alt) or asparate (ast) aminotransferase activities

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
presence of anti-hcv and hcv rna in serum tested at least once during the previous six months.
Descrizione

anti-hcv and hcv rna

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0019196
evidence of chronic hepatitis on liver biopsy done within the previous 12 months with a histology activity index of at least 6 (out of a maximum of 22).
Descrizione

evidence of chronic hepatitis on liver biopsy done within the previous 12 months with a histology activity index of at least 6 (out of a maximum of 22).

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0019196
contraindications to the use of alpha interferon, either in the form of specific contraindications to its use (depression, psychiatric illness, neurological impairment, severe thrombocytopenia, autoimmune disease), or the history of severe side effects or intolerance during a previous course of alpha interferon, or lack of a sustained virological (sustained lost of hcv rna from serum for more than six months after stopping treatment) response to an adequate course (6 months) of the combination of alpha interferon and ribavirin or (after september 1, 2003) the combination of peginterferon and ribavirin.
Descrizione

Interferon

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1610033
UMLS CUI [2]
C0035525
UMLS CUI [3]
C0982327
written informed consent.
Descrizione

written informed consent.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
inclusion criteria for patients in 98-dk-0003:
Descrizione

inclusion criteria for patients in 98-dk-0003:

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1512693
an important group of patients who were enrolled in the current study, were patients who participated in the clinical research protocol 98-dk-0003 (combination of alpha interferon with long-term ribavirin for patients with chronic hepatitis c) and who did not have a sustained virological response to this treatment. these patients were eligible to enroll into the current study once they had finished the therapy and follow up period in that trial. these patients fit the inclusion criteria listed above with one exception: some patients were receiving ribavirin monotherapy as a part of their participation in 98-dk-0003. these patients were eligible to be immediately enrolled into this study without a medication-free period in between.
Descrizione

clinical research protocol 98-dk-0003

Tipo di dati

boolean

Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregancy or, in women of childbearing potential, inability to practice adequate contraception. men with spouses or sexual partners of childbearing potential also be excluded if they are unable to practice adequate contraception.
Descrizione

pregancy and contraception

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0700589
significant systemic illnesses other than liver disease, including a history of congestive heart failure, cerebral vascular disease, renal failure (creatinine clearance less than 50 ml/min), and angina pectoris.
Descrizione

significant systemic illnesses

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0009488
patients with an abnormal stress test or carotid untrasound will not be enrolled into this study.
Descrizione

abnormal stress test or carotid untrasound

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1384495
UMLS CUI [2]
C0948945
pre-existing anemia (hematocrit less than 32%) or known history of hemolytic anemia.
Descrizione

anemia

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0002871
interferon or immunosuppressive therapy within the last 6 months.
Descrizione

interferon or immunosuppressive therapy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3652465
UMLS CUI [2]
C0021081
evidence of another form of liver disease in addition to viral hepatitis, such as autoimmune or alcoholic liver disease.
Descrizione

liver disease

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0023895
active or recent (within one year) alcohol or drug abuse or psychiatric illness that is likely to interfere with compliance and requirements for safety monitoring during this study.
Descrizione

active or recent (within one year) alcohol or drug abuse or psychiatric illness that is likely to interfere with compliance and requirements for safety monitoring during this study.

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
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Similar models

Eligibility Chronic Hepatitis C NCT00001854

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
age above 18 years, male or female.
Item
age above 18 years, male or female.
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
elevated alanine (alt) or asparate (ast) aminotransferase activities
Item
elevated alanine (alt) or asparate (ast) aminotransferase activities averaging at least twice the upper limit of normal on three determinations taken at least one month apart during the previous 6 months. the mean of these three determinations will be defined as "baseline" alt and ast levels.
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
anti-hcv and hcv rna
Item
presence of anti-hcv and hcv rna in serum tested at least once during the previous six months.
boolean
C0019196 (UMLS CUI [1])
evidence of chronic hepatitis on liver biopsy done within the previous 12 months with a histology activity index of at least 6 (out of a maximum of 22).
Item
evidence of chronic hepatitis on liver biopsy done within the previous 12 months with a histology activity index of at least 6 (out of a maximum of 22).
boolean
C0019196 (UMLS CUI [1])
Interferon
Item
contraindications to the use of alpha interferon, either in the form of specific contraindications to its use (depression, psychiatric illness, neurological impairment, severe thrombocytopenia, autoimmune disease), or the history of severe side effects or intolerance during a previous course of alpha interferon, or lack of a sustained virological (sustained lost of hcv rna from serum for more than six months after stopping treatment) response to an adequate course (6 months) of the combination of alpha interferon and ribavirin or (after september 1, 2003) the combination of peginterferon and ribavirin.
boolean
C1610033 (UMLS CUI [1])
C0035525 (UMLS CUI [2])
C0982327 (UMLS CUI [3])
written informed consent.
Item
written informed consent.
boolean
C0021430 (UMLS CUI [1])
inclusion criteria for patients in 98-dk-0003:
Item
inclusion criteria for patients in 98-dk-0003:
boolean
C1512693 (UMLS CUI [1])
clinical research protocol 98-dk-0003
Item
an important group of patients who were enrolled in the current study, were patients who participated in the clinical research protocol 98-dk-0003 (combination of alpha interferon with long-term ribavirin for patients with chronic hepatitis c) and who did not have a sustained virological response to this treatment. these patients were eligible to enroll into the current study once they had finished the therapy and follow up period in that trial. these patients fit the inclusion criteria listed above with one exception: some patients were receiving ribavirin monotherapy as a part of their participation in 98-dk-0003. these patients were eligible to be immediately enrolled into this study without a medication-free period in between.
boolean
Item Group
C0680251 (UMLS CUI)
pregancy and contraception
Item
pregancy or, in women of childbearing potential, inability to practice adequate contraception. men with spouses or sexual partners of childbearing potential also be excluded if they are unable to practice adequate contraception.
boolean
C0032961 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
significant systemic illnesses
Item
significant systemic illnesses other than liver disease, including a history of congestive heart failure, cerebral vascular disease, renal failure (creatinine clearance less than 50 ml/min), and angina pectoris.
boolean
C0009488 (UMLS CUI [1])
abnormal stress test or carotid untrasound
Item
patients with an abnormal stress test or carotid untrasound will not be enrolled into this study.
boolean
C1384495 (UMLS CUI [1])
C0948945 (UMLS CUI [2])
anemia
Item
pre-existing anemia (hematocrit less than 32%) or known history of hemolytic anemia.
boolean
C0002871 (UMLS CUI [1])
interferon or immunosuppressive therapy
Item
interferon or immunosuppressive therapy within the last 6 months.
boolean
C3652465 (UMLS CUI [1])
C0021081 (UMLS CUI [2])
liver disease
Item
evidence of another form of liver disease in addition to viral hepatitis, such as autoimmune or alcoholic liver disease.
boolean
C0023895 (UMLS CUI [1])
active or recent (within one year) alcohol or drug abuse or psychiatric illness that is likely to interfere with compliance and requirements for safety monitoring during this study.
Item
active or recent (within one year) alcohol or drug abuse or psychiatric illness that is likely to interfere with compliance and requirements for safety monitoring during this study.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
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